The present invention relates to a mild antimicrobial detergent composition which is particularly suited for use as a surgical scrub. To be suitable for use as a surgical scrub, a composition must be antiseptic as well as mild.
Effective antiseptic or disinfectant compositions can be formed by combining a detergent with an antimicrobial agent. Thus, antiseptic cleaning compounds can be formulated rather easily; however, many such compositions are not suitable for use in contact with human skin. Where the composition is intended for use as a surgical scrub mildness is an important consideration. Mildness as used herein indicates the composition does not cause excessive irritation of the skin, such as erythema, from the contact of the composition with the skin.
In a majority of cases, skin irritations can be attributed to contact of the skin with a detergent. It is believed that skin irritation results partly due to a nature of the detergent itself and, in part, due to the action of the detergent in weakening the resistance of the skin. The degree of irritation may vary significantly with the detergent, the individual user, the length of contact and the conditions of contact. In many cases the degree of irritation is also affected by other chemicals which are combined with a detergent.
While the cause of skin irritation is not clearly understood, it is believed that detergents have a denaturing effect on the keratin layer of the skin. Thus, chemicals which normally do not irritate the skin when combined with a detergent can penetrate the skin and cause irritation. Furthermore, some chemicals when combined with a detergent may be more readily absorbed by the skin. The absorption of the other chemicals is generally undesirable, especially those which are harmful or toxic to the body.
Numerous attempts have been made to develop additives or formulations which reduce or eliminate skin irritation. Thus far there has been limited success in providing a mild surgical scrub composition. Surgical scrub procedures and surgical techniques are highly conducive to the development of erythema and other irritations. All personnel involved in surgical procedures employ the surgical scrub in preparation for surgery. Frequently, the same individual will scrub three to five times on a single day. A typical surgical scrub involves placing an antimicrobial cleansing solution on the hand. Commonly a brush or sponge is used and the arms from the elbows to the fingertips are scrubbed thoroughly for as long as ten minutes. Thus, the epidermal layers of the skin are subjected to significant rubbing and aggravation. After the arms and hands have been scrubbed they are rinsed, dryed and placed into rubber gloves. The rinse is often not complete and residual detergent and/or antimicrobial compounds are left on the skin. Many times, the hands remain gloved for as long as six hours. During this time the hand perspires and the pores can open and enlarge, thereby allowing residual detergent and/or antimicrobial compounds to penetrate the skin. This in turn can create topical skin irritations. The likelihood of irritation or erythema increases with the frequency one performs the surgical scrub procedure. Thus, it is important that surgical scrub compositions be very mild.
In addition, the surgical scrub can be even more hazardous where the antimicrobial agent is toxic to humans. For example, hexachlorophene (HCP) is a known antimicrobial agent and is utilized in commercial antibacterial skin cleansers. These HCP containing cleansers have been utilized in surgical scrub procedures. Evidence has come to light which demonstrates that HCP when used in topical products can be absorbed by the body in dangerously high levels. Hexachlorophene has been associated with brain stem damage, as well as central nervous system damage. The Food and Drug Administration and the medical community have discouraged the use of HCP because of its toxicity.
The two prevalent surgical scrubs contain either iodophor or hexachlorophene. To discontinue the use of hexachlorophene would cause a gap in products available as a surgical scrub, because a substantial portion of the population, perhaps up to 20%, is allergic to surgical scrubs containing iodine in the form of iodophor.
Thus, a need has arisen for a surgical scrub composition which is very mild and which preferably contains an antimicrobial agent which is nontoxic or exhibits low toxicity to humans, and to which few individuals are allergic.